Navitor Japan Study

Abbott

Status: Enrolling

Conditions: Severe Aortic Stenosis

Treatments: Device: Navitor Transcatheter Aortic Valve Implantation

Study type: Observational

Funder types: Industry

Identifiers

NCT07193888

ABT-CIP-10599

Details and patient eligibility

About

The Navitor Japan Study is designed to evaluate the safety and performance of the Navitor™ valve used in combination with the FlexNav™ delivery system in a contemporary, real-world setting.

Full description

A prospective, single-arm, observational, multicenter post-market clinical study enrolling approximately 100 Japanese patients with symptomatic, severe aortic stenosis. The study will evaluate the safety and performance of the Navitor TAVI system, including future commercially available iterations, as they become available in Japan. Enrolled subjects will undergo follow-up at discharge, 30 days and 1-year post-index procedure.

Enrollment: 100 estimated patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patient is eligible per the current approved indication after Heart Team discussion and intended to undergo a Navitor TAVI procedure.
2. The patient has been informed of the nature of the study, agrees to its provisions, and has provided written informed consent as approved by the EC of the respective clinical site.
3. The patient and the treating physician agree that the subject will return for all required post-procedure follow-up visits

Exclusion criteria

1. Patient is not eligible for the Navitor TAVI System per the current Instructions for Use (IFU).
2. Life expectancy < 12 months from the time of informed consent due to non-cardiac co-morbid conditions.
3. In the judgment of the Investigator, patient presents with a medical, social, or psychological condition that could limit the ability or willingness to participate in the study, comply with study required testing and/or follow-up visits or that could impact scientific integrity of the study.
4. Known contraindication for computed tomography (CT) or sensitivity to contrast media, which cannot be adequately premedicated.
5. Inability to tolerate antiplatelet/anticoagulation therapy or nitinol alloy (nickel and titanium), which cannot be adequately premedicated.
6. Currently participating in an investigational drug or device study that may confound the results of this study.
7. Anatomy that makes insertion and endovascular access to the aortic valve difficult and/or impossible.

Trial design

100 participants in 1 patient group

Cohort 1

Description:

This study will enroll subjects of all genders from the population of patients qualifying for TAVI.

Treatment:

Device: Navitor Transcatheter Aortic Valve Implantation